# 2026-01288: FDA Drops Guide for Testing Wrist-Worn Blood Pressure Gadgets

2026-01288, Cuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-01-23, effective Submit either electronic or written comments on the draft guidance by March 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2026-01288
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-01288
- Title: Cuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 2939
- Published: 2026-01-23
- Effective: Submit either electronic or written comments on the draft guidance by March 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Comments close: 2026-03-24
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Drops Guide for Testing Wrist-Worn Blood Pressure Gadgets

## Summary

The FDA just dropped a draft guide for companies making cuffless blood pressure devices, showing how to test and prove their gadgets work well. This affects device makers aiming to get FDA approval and helps make sure your new tech is safe and accurate. Comments on this draft are open until March 24, 2026, so get your thoughts in before then!

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Cuffless Non-invasive Blood Pressure Measuring Devices--Clinical Performance Testing and Evaluation." This draft guidance provides recommendations for clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring devices. This draft guidance is not final nor is it for implementation at this time.

## Effects PRIA read

- Draft testing guidance for cuffless BP devices: benefit, low. The FDA released a draft guidance titled "Cuffless Non-invasive Blood Pressure Measuring Devices--Clinical Performance Testing and Evaluation" that gives recommendations for clinical performance testing and evaluation to support premarket submissions for cuffless blood pressure measuring devices. T…
- Comment opportunity and deadline: benefit, low. Stakeholders may submit electronic or written comments on the draft guidance; comments must be submitted by March 24, 2026 for the Agency to consider them before it begins work on the final guidance. The docket number for comments is FDA-2025-D-0851 and submissions go through Regulations.gov or by…
- No new paperwork collection required: benefit, low. The draft guidance states it contains no new collection of information under the Paperwork Reduction Act and instead refers to previously approved FDA collections with OMB control numbers 0910-0120, 0910-0844, 0910-0756, and 0910-0485. These existing approvals cover premarket notification, De Novo…

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## Sources
- [2026-01288 on federalregister.gov](https://www.federalregister.gov/documents/2026/01/23/2026-01288/cuffless-non-invasive-blood-pressure-measuring-devices-clinical-performance-testing-and-evaluation)
- [2026-01288 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01288.pdf)

## Related
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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-01288 (as of 2026-06-08).